Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Tuesday, February 28, 2017 Daily Archives

MilliporeSigma’s new Integritest® 5 instrument is an easy-to-use, portable and fully automated integrity test system for verification of filters and processing equipment. The latest model of the first commercially available automated integrity test instrument introduced more than 25 years ago now incorporates an improved algorithm to simplify test creation and accelerate test completion. The user-friendly software makes it easy to set up and manage users and tests, while offering a depth of advanced functionality for those who need additional options.…